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| ID | Type | Description | Link |
|---|---|---|---|
| REMICADEART4005 |
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The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes pain, swelling, stiffness and loss of function in joints) in participants with moderate disease versus participants with severe disease and to compare the efficacy and safety of the MTX subgroups.
This is an open-label (all people know the identity of the intervention), multi-center (study conducted in more than 1 center), prospective (study following participants forward in time) study comparing the American College of Rheumatology (ACR) scores of participants with moderate RA (defined as having a score greater than 3.2, but less than 5.1 on the Disease Activity Score 28 [DAS 28]) to those participants with severe RA (defined as having a score greater than 5.1 on the DAS 28 score) disease while being treated with infliximab and MTX. DAS evaluates RA activity by several parameters including the number of swollen and tender joints and the participant's own assessment of their pain. Participants will receive infliximab 3 milligram (mg) per kilogram (kg) intravenous infusion (drug given into a vein) (over no less than 2 hours) at Weeks 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 Weeks. Participants will have a follow-up visit on Week 26. Efficacy will primarily be assessed by the percentage of participants obtaining ACR20, ACR50 and ACR70 response at Week 26. Participants' safety will be assessed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab + Methotrexate (Moderate RA) | Experimental | Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activity score [DAS] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX IN a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks. |
|
| Infliximab + Methotrexate (Severe RA) | Experimental | Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (mg/week) equal to the dose used before participation in the study) for 22 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response | ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP). | Week 26 |
| Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response | ACR50 is achieved if the participant has 50% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP). | Week 26 |
| Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response | ACR70 is achieved if the participant has 70% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP). | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Swollen Joints Count at Week 26 | Number of swollen joints were determined by examination of 28 joints and identifying when swelling is present. The number of swollen joints was recorded on the joint assessment form at each visit; the swelling was graded on a scale ranging from 0-2 (0=no swelling, 1=swelling, but bony landmarks seen, 2=swelling but bone marks not seen). Participants categorized as Hepatitis B Virus antigen (HBsAb) positive/negative (at least 1 of HbsAg, HBeAg, Anti-HbeAg and Anti-HbcAg were positive or all were negative). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd. Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Infliximab + Methotrexate (Moderate Rheumatoid Arthritis [RA]) | Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activitiy score [DAS] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks. |
| FG001 | Infliximab + Methotrexate (Severe RA) | Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab + Methotrexate (Moderate RA) | Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response | ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP). | Full analysis set (FAS) included participants who received at least 1 dose of study medication and had post efficacy data. | Posted | Number | Percentage of participants | Week 26 |
|
Baseline up to Week 26
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infliximab + Methotrexate (Moderate RA) | Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tuberculosis | Immune system disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Affairs | Xian-Janssen Pharmaceutical Ltd | (8610) 5821 8359 |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Methotrexate | Drug | MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks. |
|
| Baseline and Week 26 |
| Change From Baseline in Tender Joints Count at Week 26 | Number of tender joints was determined by examination of 28 joints and identifying when tenderness is present. The number of tender joints was recorded on the joint assessment form at each visit; the tenderness of symptomatic joints was graded on a scale ranging from 0-3 (0=no pain, 1=mild, 2= moderate and 3=severe). | Baseline and Week 26 |
| Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26 | Participant's pain was assessed on VAS of 0 to 100 mm (0=not at all to 100=extreme pain). | Baseline and Week 26 |
| Change From Baseline in Participants' Global Disease Assessment at Week 26 | Participants scored the overall disease state using VAS of 0-100 mm. Participants might have assessed the Control of their current disease using "0 mm=very good" to "100 mm=very poor" scale. | Baseline and Week 26 |
| Change From Baseline in Physicians' Global Disease Assessment at Week 26 | Physicians scored the overall disease state using VAS of 0-100 mm. Physicians might have assessed the activity of RA using "0=no active RA" to "100=most serious active RA" scale. | Baseline and Week 26 |
| Change From Baseline in Duration of Morning Stiffness at Week 26 | Duration of morning stiffness: Time elapsed in minutes when participant woke up in morning and was able to resume normal activities without stiffness. Increase in stiffness duration from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | Baseline and Week 26 |
| Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26 | The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0=no difficulty to 3=inability to perform a task in that area. | Baseline and Week 26 |
| Change From Baseline in C-Reactive Protein (CRP) at Week 26 | CRP is a protein found in the blood, the levels of which rise in response to inflammation. | Baseline and Week 26 |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26 | ESR is also called a sedimentation rate or Westergren ESR, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test, and is a non-specific measure of inflammation. | Baseline and Week 26 |
| Lost to Follow-up |
|
| Other |
|
| BG001 | Infliximab + Methotrexate (Severe RA) | Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Infliximab + Methotrexate (Severe RA) | Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks. |
|
|
| Primary | Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response | ACR50 is achieved if the participant has 50% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP). | The FAS population included participants who received at least 1 dose of study medication and had post efficacy data. | Posted | Number | Percentage of participants | Week 26 |
|
|
|
| Primary | Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response | ACR70 is achieved if the participant has 70% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP). | The FAS population included participants who received at least 1 dose of study medication and had post efficacy data. | Posted | Number | Percentage of participants | Week 26 |
|
|
|
| Secondary | Change From Baseline in Swollen Joints Count at Week 26 | Number of swollen joints were determined by examination of 28 joints and identifying when swelling is present. The number of swollen joints was recorded on the joint assessment form at each visit; the swelling was graded on a scale ranging from 0-2 (0=no swelling, 1=swelling, but bony landmarks seen, 2=swelling but bone marks not seen). Participants categorized as Hepatitis B Virus antigen (HBsAb) positive/negative (at least 1 of HbsAg, HBeAg, Anti-HbeAg and Anti-HbcAg were positive or all were negative). | The FAS population included participants who received at least 1 dose of study medication and had post efficacy data. | Posted | Mean | Standard Deviation | Swollen joints | Baseline and Week 26 |
|
|
|
| Secondary | Change From Baseline in Tender Joints Count at Week 26 | Number of tender joints was determined by examination of 28 joints and identifying when tenderness is present. The number of tender joints was recorded on the joint assessment form at each visit; the tenderness of symptomatic joints was graded on a scale ranging from 0-3 (0=no pain, 1=mild, 2= moderate and 3=severe). | The FAS population included participants who received at least 1 dose of study medication and had post efficacy data. | Posted | Mean | Standard Deviation | Tender joints | Baseline and Week 26 |
|
|
|
| Secondary | Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26 | Participant's pain was assessed on VAS of 0 to 100 mm (0=not at all to 100=extreme pain). | The FAS population included participants who received at least 1 dose of study medication and had post efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 26 |
|
|
|
| Secondary | Change From Baseline in Participants' Global Disease Assessment at Week 26 | Participants scored the overall disease state using VAS of 0-100 mm. Participants might have assessed the Control of their current disease using "0 mm=very good" to "100 mm=very poor" scale. | The FAS population included participants who received at least 1 dose of study medication and had post efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 26 |
|
|
|
| Secondary | Change From Baseline in Physicians' Global Disease Assessment at Week 26 | Physicians scored the overall disease state using VAS of 0-100 mm. Physicians might have assessed the activity of RA using "0=no active RA" to "100=most serious active RA" scale. | FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 26 |
|
|
|
| Secondary | Change From Baseline in Duration of Morning Stiffness at Week 26 | Duration of morning stiffness: Time elapsed in minutes when participant woke up in morning and was able to resume normal activities without stiffness. Increase in stiffness duration from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. | FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data. | Posted | Mean | Standard Deviation | Minutes | Baseline and Week 26 |
|
|
|
| Secondary | Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26 | The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0=no difficulty to 3=inability to perform a task in that area. | FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 26 |
|
|
|
| Secondary | Change From Baseline in C-Reactive Protein (CRP) at Week 26 | CRP is a protein found in the blood, the levels of which rise in response to inflammation. | FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data. Here, 'N' signifies participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Milligram/Liter | Baseline and Week 26 |
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|
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| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26 | ESR is also called a sedimentation rate or Westergren ESR, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test, and is a non-specific measure of inflammation. | FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data. | Posted | Mean | Standard Deviation | Millimeter/1 hour | Baseline and Week 26 |
|
|
|
| 2 |
| 104 |
| 57 |
| 104 |
| EG001 | Infliximab + Methotrexate (Severe RA) | Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks. | 2 | 130 | 80 | 130 |
| Fungal pneumonia | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Septicemia | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Hypolekocytosis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Hepatic function disnormal | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA | Non-systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |